»Training and Continuing Education

Investigators wishing to conduct research with human subjects through Chapman University's IRB MUST complete training on human subject research protection through Collaborative Institutional Training Initiative (CITI) https://about.citiprogram.org/, prior to submitting an application to the IRB. CITI offers two courses on human subject protections: 

1. "Biomedical Research" (note: the course "Biomedical Responsible Conduct of Research Course" does not replace the "Biomedical Research" course)
2. "Social and Behavioral Research" (note: the course "Social and Behavioral Responsible Conduct of Research Course" does not replace the "Social & Behavioral Research Investigators" course)

CITI training for either course (1), or (2) is acceptable. The PI has discretion as to which of such two courses is appropriate for the specific research team member, as part of the PI's responsibilities PI Responsibilities | Chapman University. The training must be current and not expiring within the next 3 months of submitting an application to the IRB. 

• For non-Chapman investigators - the investigators need not affiliate with Chapman in completing either of the two courses (e.g., the course may have been completed under another institution/non-Chapman university).
• For Chapman investigators (e.g., faculty/staff/students) - the investigators must affiliate with Chapman in completing either of the two CITI courses. If they had completed a similar course in a previous institution, they must affiliate with Chapman to enable two things to occur: completion of any Chapman-specific CITI modules, and CITI credits earned at other institutions can carry over to the investigator's CITI profile under Chapman. 

Training in Good Clinical Practices (GCP): Completion of GCP training is required for all research team member involved in the design, conduct, oversight, or management of a study that meets at least one of these criteria:

     1.  The study is a “clinical trial” as defined by NIH and is funded by the NIH, or

     2.  The study involves an investigational medical device or drug

Valid GCP training is prerequisite to approval of the study by the IRB. Such training is valid for 3 years. Researchers should complete the applicable CITI GCP course depending on the classification of the research: 

• GCP for Clinical Investigations of Devices
• GCP - Social and Behavioral Research Best Practices for Clinical Research

Note that this GCP training is in addition to basic IRB human subjects training required for researchers on expedited and full board review studies.

After the required CITI modules are completed, investigators must complete the modules once every three years. Completion time of the required module(s) can range between 30 minutes to a few hours, as modules can be completed at each investigator's own pace and leisure.

NOTE: An IRB application cannot be processed until all personnel have completed the required CITI Training.

CITI Set Up Account Instructions 

List of Required Modules for Social & Behavioral Research